FDA clears expanded matrix of Glider PTCA balloon catheter

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The US Food and Drug Administration (FDA) has given clearance to TriReme Medical for an expanded matrix of sizes for its Glider PTCA balloon catheter. Glider is now approved for the treatment of lesions in the coronary vasculature in balloon diameters from 1.5 – 3.5mm and in lengths from 4mm to 20mm. 

“Glider provides interventional cardiologists with an entirely new degree of control during the treatment of complex side branches and total occlusions,” said David Rizik, medical director and interventional cardiologist at Scottsdale Heart Group, Scottsdale, USA. “With its torqueable shaft and ultra short 4mm length, I am amased that such a clever design can provide such powerful clinical benefits. Glider has become my ‘go-to’ balloon when I approach the treatment of my most challenging cases.”

“Our recent experience in Europe demonstrates Glider’s ability to outperform conventional ‘best in class’ balloon catheters,” said Eitan Konstantino, president and CEO of TriReme Medical. “TriReme now has three product families that have received regulatory approval in the United States. I am proud of our development team that continues to bring to market ‘out-of-the-box’ solutions to simplify complex interventional procedures.”